“AssurX…allowed easy management of all CAPAs on a local level as well as knowledge exchange between management throughout the global organization.”

– Manager, Global Quality
Info Systems

Life Sciences Enterprise Quality Management

Maintaining the highest quality levels and strict regulatory compliance affects the bottom line and can be a matter of life and death for medical device, biotechnology, and pharmaceutical manufacturers. To protect both companies and consumers, and meet increasingly tough FDA and other regulatory body demands, it’s essential to understand and meet the challenges of global corrective and preventive action (CAPA), complaints management, change control, audit management, supplier quality, and overall product quality management. In addition to the FDA’s stringent 21 CFR Part 11, 54 and 58 requirements, companies face serious regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon life science manufacturers to use software, hardware, and system processes that ensure only those personnel required to see a given piece of data are in fact allowed to access it. AssurX software is designed with enterprise quality management, cGXP, and life science-specific regulatory requirements in mind. Successful life science companies are using the AssurX QMS software platform to centrally monitor, manage and improve their quality and regulatory compliance processes—and the bottom line—across all operations.

“Companies such as 3M expect a field-proven solution, and AssurX delivers not only the product, but a high level of expertise.”

Enterprise Quality Management Built for FDA Compliance

AssurX quality management system software is designed to support requirements and standards for FDA regulated industries. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document and report all quality and compliance issues across every part of operations—even into the supply chain. Using AssurX’s closed-loop quality management and software, you not only know immediately when an issue arises (from any source: customer, supplier, internal), all relevant areas of your organization share the information needed to contain, evaluate and quickly resolve the problem. Using powerful, real-time analytical tools the software helps companies identify, assess and remediate risk exposure; perform the detailed trend analysis needed to prevent quality and compliance problems and continually improve operations. AssurX boasts mature compliance management capabilities with extensive audit trails, security controls, and electronic signature and records functionality that meets or exceeds rigorous standards regulatory requirements. Not only fully compliant with 21 CFR Part 11 and Part 820, it is also flexible enough to keep you in compliance with changing cGXP requirements. AssurX’s preconfigured closed-loop solutions deliver fully FDA-compliant processes to manage complaints, supplier quality, document control, CAPA, change, audits, and more, while a state of control and proof of compliance is maintained continuously in one central, securely accessible system. The AssurX software is validated and comes with IQ/OQ validation templates. Each pre-configured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.

FEATURES

AssurX delivers central control and improved compliance and business performance.

CAPA Integration

Automatically track, trend, resolve and document all product issues—initiated from any source, across all functional areas—before they become costly or dangerous problems. Reduce and prevent quality incidents. Control costs and make better product the first time around.

Compliance-Ready

Designed to meet changing cGXP, HHS and other FDA regulations, the software guides users step-by-step through the process to meet requirements. Preconfigured forms contain all pertinent information blocks required for compliance and smooth operations, dramatically reducing the risk of non-compliance.

Business Intelligence

Enterprise Intelligence With Dashboards, KPIs & Metrics: Get real-time trending and global oversight with graphical dashboards and analytics that deliver instant business intelligence, accessed anywhere with an Internet connection.

eSignatures

eSignatures, 21 CFR Part 11: AssurX’s solution is designed to meet or exceed this important regulation’s strict audit trail and e-data integrity requirements.

Guaranteed HIPAA

Make certain e-data is open only to those who are allowed to see it. AssurX makes it easy to “lock out” those who aren’t authorized to view any e-data field that requires shielding.

Risk-based Quality Management

Built-in risk assessment features for critical QMS processes such as CAPA and a robust Risk Management solution helps you prioritize activities and meet ISO standards for “risk-based thinking” in quality management systems.

Automatically capture detailed data about quality problems from anywhere in the operation with the streamlined AssurX CAPA solution. Get real-time trending of out-of-specification, out-of-trend, and other deviations. Control costs, and improve products while meeting regulatory requirements for closed-loop quality management with electronic records and signatures, and time-stamped audit trails. Because it’s fully integrated with other quality related processes such as audits, nonconformance, complaints, etc., no matter where an issue originates, or how many departments the problem touches, the system can effectively manage its resolution.

“Companies such as ours expect a CAPA system that delivers, and demand expertise from a software company who has spent years in FDA-regulated industries.”

Audit Trail, Electronic Signatures

Every AssurX solution comes fully compliant to 21 CFR Part 11. Once added to a specific record, signatures cannot be modified, copied, transferred, or deleted. Signatures can be of various types (approval, acknowledgement, etc.) and comments may be included with each. AssurX automatically maintains a secure, time-stamped compliant record archive (audit trail) of all changes made to any electronic record. Records and changes are displayed together in their entirety.

Query on every audit trail

Audit trail on file attachment modifications

View edit changes on forms in the audit trail showing the before/after field values

The AssurX Complaints Management and Regulatory Reporting system provides a best practices process for managing the entire event lifecycle from event intake through investigation, root cause analysis and reporting to regulatory agencies. It features proven best practice matrixes, management dashboards and strong audit trail reports and controls.

AssurX’s solution delivers a comprehensive audit management process that adheres to current best practices for closed-loop findings; closure, task assignments and escalation. Audits are conducted after being planned, findings are classified and follow-up is assigned to the right personnel. After follow-up actions are addressed, a final report is issued and routed for complete closure.

“AssurX rose to the top right from the beginning. We were impressed by AssurX’s capabilities such as configurability, ease of use and better ROI. We’re very happy with what AssurX has already helped us to do, and we are looking forward to even greater achievements in the future.”

Manufacturing Quality Management

Globally document, track and resolve manufacturing related quality issues such as nonconformance, deviations, defects, incidents, exceptions, and change requests, from initiation through disposition, corrective action and change execution. This closed-loop system is fully integrated with other quality and compliance processes and follows ISO and GMP standards for best practices. Track trends, cycle times and costs to facilitate root cause analysis and improve efficiency.

AssurX’s SQM solution offers instant collaboration and visibility across your supplier network to vastly improve product quality. No matter the number or location of your suppliers and contract manufacturers, SQM lets you quickly detect, inspect, track, trend and contain supplier related quality issues quickly and correct them before they become bigger issues.

“With AssurX, we have significantly improved our efficiency and productivity.”

Change Management

A flexible, central system orchestrates, tracks and documents changes across all functional areas of a business. It creates a consistent, compliant closed-loop method to process any type of change (e.g. business process, product design, documentation, etc.). Proposed changes initiated from any department are evaluated; change plans are mapped out; tasks, reviews, and approvals assigned and tracked; then approved changes are released and implemented across operations, and training programs for new materials are initiated. With easy, full integration to other quality related processes, it keeps coordinated control over changes across the organization.

AssurX’s solution provides integrated, easy and effective management of controlled content throughout its life cycle—from change orders through release approval, dissemination and training. Get rapid, secure access to current and accurate documents at all times. AssurX Document Management allows businesses to improve global visibility of process changes, reduce risk and labor costs associated with use of erroneous and outdated procedures, and demonstrate regulatory compliance to inspectors.

Take charge of all training requirements, activities, materials/courses and histories throughout your organization. Quickly identify “who-needs-what” training even in complex, changing environments. The AssurX solution ensures your personnel are always effectively trained for the job, all training is properly documented and training histories are accessible, auditable and correctly reported when necessary.

Download the Life Science
Complaints Management and
Regulatory Reporting Brochure

AssurX solutions follow industry standards and best practices for closed-loop quality systems for medical devices, pharmaceutical and other life science industries. The system guides the process of determining the reportability of every complaint using decision-tree processing, automating the evaluation of reporting requirements for the US FDA, Canada, Europe, and Australia. Automatically manage report due dates and notify assignees when reporting tasks become due or past due. Generate MedWatch 3500A and other vigilance reports in PDF format. Generate follow-up and supplemental reports based on changes to previously submitted reports.

AssurX eMDR provides a closed-loop, end-to-end automated reporting system without the requirement of any additional third party tools or EDI systems. Everything is built-in, ready to go. MedWatch 3500A and other vigilance reports can be generated and submitted directly from the system. The solution delivers improved on-time reporting that also substantially improves accuracy and productivity in your reporting process.

“We felt AssurX’s ease of configurability allowed us to continue to adapt our processes and solutions to Genzyme’s increasing product portfolio, facilities and international markets.”